QMS Administrator

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NeilMed Pharmaceuticals Inc

Job Category

Information Technology

Job Level

Mid-Level

Job Type

Full time

Job Location

USA, Santa Rosa, CA

Job Description

Key Responsibilities:

  • Responsible for the elicitation and analysis of change requests in collaboration with Process Owner and stakeholders, and translate them into structured change requests
  • Update change requests when needed and keep up to date information of the system change request
  • Responsible for identifying the design of the QMS application and follow established best practices internally to document, design, configure the application based on Stakeholder inputs
  • Prepares test cases and scripts that are relevant to the design and functional requirements while adhering to the software validation requirements of 21 CFR Part 11
  • Plan and implement the Software testing for QMS module
  • Primary point of contact for all testing needs
  • Maintain and update test cases for all future changes
  • Maintain bug tracker and adhere to the SDLC best practices for trace ability of the changes
  • Prepare training materials when needed
  • Conduct training sessions to the users for all changes implemented during software release
  • Publish Release notes for software release schedules
  • Prepare software release schedule and ensure to follow the schedule for all phases of SDLC
  • Prepare monthly, quarterly and yearly QMS reports
  • Educate users on the regulatory requirements of the systems
  • Work on Process improvement methodology to innovate and improve existing systems

Education:

  • Bachelor’s degree or equivalent experience; experience in 21 CFR part 11 guidelines is preferred

Skills & Requirements

  • 3+ year experience in working on the application support, change requests and software documentation is preferred
  • 2+ year experience in working in SDLC
  • Proficient in Microsoft Office products, such as PowerPoint, Excel, and Visio
  • Knowledgeable in all aspects of the Systems Development Life Cycle (SDLC)

Competencies:

  • Effective communication, collaboration, team player.

How to Apply

Send resume to jobs@neilmed.com



About Company

NeilMed Pharmaceuticals is a leading manufacturer in nasal saline OTC products. We are committed to providing exceptional customer service and satisfaction. We ensure that our products meet the highest level of quality and safety standards. We are always looking for experienced, self motivated, hard working, and dependable individuals to join our rapidly growing company. Qualification requirements will vary depending upon the job you are applying for. We offer competitive salary and benefits.

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